93/42/EEC Commission communication in the framework of the implementation of the Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance; Publication of titles and references of harmonised standards under the directive)
EN 1041 Information supplied by the manufacturer of medical devices
IEC 60079-4:1975 Electrical apparatus for explosive gas atmospheres. Part 4 : Method of test for ignition temperature
IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) (Edition 2.1 ***Applies to French text only***)*, 2023-12-23 Update
IEC 60601-1-11:2010 Medical electrical equipmentPart 1-11:General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-12:2014 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical service
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*, 2023-12-23 Update
IEC 62366 Medical devices - Application of usability engineering to medical devices
ISO 10079-2 Medical suction equipment — Part 2: Manually powered suction equipment*, 2022-03-16 Update
ISO 10079-3 Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive pressure gas source*, 2022-03-16 Update
ISO 10651-4 Lung ventilators — Part 4: Particular requirements for user-powered resuscitators*, 2023-03-06 Update
ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice*, 2020-07-28 Update
ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*, 2019-12-10 Update
ISO 15223-1 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1
ISO 3744 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane
ISO 5356-1 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
ISO 7000 Graphical symbols for use on equipment — Index and synopsis*, 2019-07-12 Update
ISO 80369 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications*, 2021-04-30 Update
ISO 8836 Suction catheters for use in the respiratory tract*, 2019-12-10 Update
BS EN ISO 10079-1:2015 history
2022BS EN ISO 10079-1:2022 Medical suction equipment. Electrically powered suction equipment